The Indian Council of Medical Research (ICMR) and the Central Drugs Standard Control Organization (CDSCO) have jointly developed a 'Handbook for Applicants and Reviewers of Clinical Trials of New Drugs in India'. The main objective is to guide applicants and reviewers of clinical trial applications and commercialization (import, manufacture, sale) of new experimental drugs (INDs) and new drugs (NDs) in the country
The development of this handbook is important because the Government of India's "Make in India", Skills Development and Universal Health initiatives have provided opportunities and incentives for the development of new drugs in India. The ICMR Board of Directors, at its meeting on January 16, 2016, highlighted the importance of clinical trials on the development of new drugs.
The approval of clinical trials and the import, manufacture and sale of new drugs is granted by COSCO, assisted by a critical evaluation of the expert committees and by the ICMR.
This handbook is designed to increase the effectiveness and quality of the review and highlights the regulatory, administrative and scientific review processes that should be followed by applicants and reviewers of new drugs or clinical trials. It focuses on the critical elements of pharmaceutical, preclinical, toxicological, clinical and information data on prescribing requirements. It focuses on assessing the demand for risk in relation to benefits, innovation in relation to existing therapies, unmet medical need, ethical aspects of patient safety, India.
In view of the increase in new drug development, it was felt that there is need to enhance capacity for regulatory review of clinical trials in the country.
The handbook will be dynamic and will be subject to revisions in line with developments and regulations. It will be available on the ICMR and COSCO websites and will be the backbone of the capacity building workshops for subject matter experts to review applications for clinical trials of new drugs.
